First in Human (FIH) study to characterize the safety, tolerability, pharmacokinetics (PK), distribution, radiation dosimetry, and anti-tumor activity of \[177Lu\]-NeoB in patients with advanced solid tumors known to overexpress GRPR and with \[68Ga\]-NeoB lesion uptake.
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Phase I: Incidence of dose limiting toxicities (DLTs) of [177Lu]-NeoB
Timeframe: Within 42 days following the first administration of [177Lu]-NeoB
Phase I: Determination of Maximum Tolerated Dose (MTD)/ Recommended phase two dose (RP2D) of [177Lu]-NeoB
Timeframe: Within 42 days following the first administration of [177Lu]-NeoB
Phase IIa (Cohorts A, B and C): Individual clinical responses assessed by Response Evaluation Criteria In Solid Tumors (RECIST v1.1)
Timeframe: 25 months
Phase IIa (Cohort E): Absorbed radiation doses of [177Lu]-NeoB in organs and tumor lesions
Timeframe: 6 weeks
Phase IIa (Cohort E): Concentration of [177Lu]-NeoB in blood over time and derived PK parameters
Timeframe: 6 weeks
Phase I: identify maximum tolerated and/or recommended Phase II dose
Timeframe: 18 months
Phase II: assess disease control rate 20 weeks after completion of treatment
Timeframe: 18 months